Keratoconus Clinical Trial
Official title:
Variability of Pentacam-derived Back Elevation Measurements in Keratoconus and Cross-linked Corneas
Primary objective of this study was to assess the intrasession, intersession and interobserver variability of the Pentacam-derived posterior corneal elevation measurements in keratoconus eyes and eyes that underwent Corneal Collagen Cross-liknking (CxL) treatment due to progressive keratoconus.
The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version
1.14r04) was used for the sake of the study.Two study groups were formed: 1) Keratoconus
group (KC) included patients with progressive keratoconus and 2) Collagen-Cross-linking
group (CXL) included keratoconus patients that had been treated with uneventful CXL at least
on year prior to their enrollment in the study.
Three consecutive scans were obtained by two experienced operators. The same procedure was
repeated within two weeks for the assessment of intersession variability. In all cases
acceptable maps had at least 10.0mm of corneal coverage.All back elevation points were
codified in order to facilitate statistical processing of data. Further to single point
analysis, three additional parameters were evaluated: a) zone 4 parameter (z4) which derived
by the analysis of all points at the central 4.0mm diameter zone, b) zone 8 parameter (z8)
which derived by the analysis of all points at the central 8.0mm diameter zone, and, c)
highest elevation point parameter (HEP), which derived by the analysis of the highest
elevation points for all participants. Reproducibility of measurements was evaluated by
means of intraclass correlation coefficients (ICC). Three different ICC types were
calculated: a) intrasession ICC for both operators (ICC1 & ICC2), b) interobserver ICC, and,
c) intersession ICC. Moreover, Bland-Altman plots were used to evaluate the level of
agreement between the two operators.
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